Contrast-Enhanced Ultrasound Evaluation of Radioembolization Treatment Response

Following baseline ultrasound imaging, CEUS will be performed using dual B-mode and CEUS mode. For the first injection using Lumason the approximate tumor mid-line will be imaged during breath hold until complete tumor enhancement is achieved followed by imaging sweeps through the tumor. Intermittent imaging will be performed after that. Following a 10 minute Lumason wash-out period, participants will then receive a bolus injection of Sonazoid with identical imaging protocol to Lumason for the first 60 seconds to evaluate arterial phase enhancement. Imaging sweeps of the tumor will then be obtained at 1 and 2 minutes to evaluate enhancement within the late vascular phase to detect early washout. After visualization in the late phase, imaging will resume to evaluate the Kupffer phase of contrast enhancement. Following completion of the exam, patients will be monitored for at least 30 minutes before being discharged and all data will be exported for later off-line analysis.

A total of 30 patients scheduled for TARE of a treatment naïve HCC will be enrolled over an 18-month period, allowing for a minimum of 6 months follow up. Given our estimated volume of roughly 35 eligible patients per year, this provides a relative recruitment rate of 53% which is consistent with our prior studies in HCC [9,11]. Eligible patients will be screened from our intuition's multi-disciplinary HCC tumor board (led by co-I Dr. Civan with input from other co-I's Drs. Lyshchik, Topper, and Anton).

Eligible patients will be identified by the project coordinator (Ms. Bradigan, RN) using our electronic medical records system. Additionally, eligible patients will be identified by co-Investigators Dr. Anton (who heads our HCC locoregional treatment program), Dr. Topper (who also has a robust HCC locoregional therapy census), and Dr. Civan (who oversees the Jefferson liver tumor board and transplant program). Additionally, the NCT listing will be posted on the websites of Jefferson's Kimmel Cancer Center. Eligible patients will be asked to contact the study coordinator to discuss participation. Whenever possible, the attending physician will approach the patient to discuss interest in the study. The study research coordinator will then contact the patient to explain the study. The patient will be given time to consider the risks and benefits of the study and ask questions about participation. If agreeable, the patient will then arrange with the project coordinator to come to Jefferson's center city campus to sign consent and take part in the research study.

The subject population for this study will be made up of approximately 33% women based on the patient populations at our university scheduled for TARE. The patient population of this project will reflect the population demographics found at major American urban academic health centers. The overall demographics include 66% Caucasian, 30% African American, and 4% Asian, with 10% representing Hispanic patients. Stratified analyses will be performed of this clinical study to allow us to determine if there are clinically important sex/gender and/or race/ethnicity differences and allow us to target the optimal imaging strategy to a precisely defined patient population based upon patient demographics.

Importantly, this clinical study does not meet the NIH criteria for a clinical trial because the study is not designed to evaluate the effect of the intervention on the participants (i.e., clinical intervention will not be changed based on CEUS findings at this point).